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TPLC - Total Product Life Cycle
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Device intervertebral fusion device with bone graft, lumbar
Regulation Description Intervertebral body fusion device.
Definition Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
Product CodeMAX
Regulation Number 888.3080
Device Class 2


Premarket Reviews
ManufacturerDecision
4WEB MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ACUITY SURGICAL DEVICES, LLC
  SUBSTANTIALLY EQUIVALENT 3
ADCURA, INC.
  SUBSTANTIALLY EQUIVALENT 1
AEGIS SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 2
ALPHATEC SPINE
  SUBSTANTIALLY EQUIVALENT 2
ALPHATEC SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 10
AMPLIFY SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
ARTFX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ASTURA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ASTURA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
ATLAS SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAAT MEDICAL PRODUCTS B.V.
  SUBSTANTIALLY EQUIVALENT 1
BAUI BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BENVENUE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BETHESDA MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
BIOGEND THERAPEUTICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CAMBER SPINE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
CAMBER SPINE TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
CARBOFIX ORTHOPEDICS , LTD.
  SUBSTANTIALLY EQUIVALENT 1
CARBOFIX ORTHPEDICS , LTD.
  SUBSTANTIALLY EQUIVALENT 1
CARLSMED
  SUBSTANTIALLY EQUIVALENT 1
CARLSMED, INC.
  SUBSTANTIALLY EQUIVALENT 10
CG MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHOICE SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
CLARIANCE
  SUBSTANTIALLY EQUIVALENT 2
CLARIANCE, SAS
  SUBSTANTIALLY EQUIVALENT 1
CORELINK, LLC
  SUBSTANTIALLY EQUIVALENT 1
CTL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
CURITEVA, INC.
  SUBSTANTIALLY EQUIVALENT 1
CUTTING EDGE SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 3
DEGEN MEDICAL
  SUBSTANTIALLY EQUIVALENT 5
DEGEN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
EIT EMERGING IMPLANT TECHNOLOGIES GMBH
  SUBSTANTIALLY EQUIVALENT 1
ELLIQUENCE, LLC
  SUBSTANTIALLY EQUIVALENT 1
EMINENT SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
ENZTEC LIMITED
  SUBSTANTIALLY EQUIVALENT 4
EXPANDING INNOVATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 7
FLOSPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
GBS COMMONWEALTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GENESYS SPINE
  SUBSTANTIALLY EQUIVALENT 1
GETSET SURGICAL, SA
  SUBSTANTIALLY EQUIVALENT 1
GLOBAL BIOMEDICA S.R.O.
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
GS MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ICOTEC AG
  SUBSTANTIALLY EQUIVALENT 1
IMPLANET
  SUBSTANTIALLY EQUIVALENT 1
INNOVASIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTEGRITY IMPLANTS INC. DBA ACCELUS
  SUBSTANTIALLY EQUIVALENT 1
INTEGRITY IMPLANTS, INC.
  SUBSTANTIALLY EQUIVALENT 5
INTELIVATION, LLC
  SUBSTANTIALLY EQUIVALENT 1
JEIL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
JOIMAX GMBH
  SUBSTANTIALLY EQUIVALENT 1
K2M, INC.
  SUBSTANTIALLY EQUIVALENT 1
KALITEC MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
KYOCERA MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
L&K BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
LIFE SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 17
MEDACTA INERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 3
MEDICREA INTERNATIONAL S.A.S. (MEDTRONIC)
  SUBSTANTIALLY EQUIVALENT 2
MEDICREA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 2
MEDOS INTERNATIONAL SÀRL
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK USA
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK USA, INC.
  SUBSTANTIALLY EQUIVALENT 9
MEDYSSEY USA, INC.
  SUBSTANTIALLY EQUIVALENT 2
MET ONE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
MET ONE TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
MIRUS, LLC
  SUBSTANTIALLY EQUIVALENT 2
MOBARN MEDICAL DEVICES, LLC
  SUBSTANTIALLY EQUIVALENT 1
NANOHIVE MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
NANOVIS, LLC
  SUBSTANTIALLY EQUIVALENT 1
NEXT ORTHOSURGICAL
  SUBSTANTIALLY EQUIVALENT 1
NEXUS SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
NEXXT SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 3
NGMEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 3
NU VASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 9
NVISION BIOMEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
OC MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
OMNIA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX US, LLC
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX, INC.
  SUBSTANTIALLY EQUIVALENT 2
PANTHEON SPINAL
  SUBSTANTIALLY EQUIVALENT 1
PARADIGM SPINE GMBH
  SUBSTANTIALLY EQUIVALENT 1
PRECISION SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
PRINTERPREZZ
  SUBSTANTIALLY EQUIVALENT 1
PRISM SURGICAL DESIGNS PTY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
RAED M. ALI, M.D., INC.
  SUBSTANTIALLY EQUIVALENT 1
RESTOR3D
  SUBSTANTIALLY EQUIVALENT 2
RETROPSOAS TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
SEASPINE ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 14
SHANGHAI IATRICAL-TI TECHNOLOGIES CO , LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI REACH MEDICAL INSTRUMENT CO, LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI SANYOU MEDICAL CO, LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN DAZHOU MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIGNUS MEDIZINTECHNIK
  SUBSTANTIALLY EQUIVALENT 1
SIGNUS MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SOUTHERN MEDICAL (PTY) , LTD.
  SUBSTANTIALLY EQUIVALENT 1
SOUTHERN SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
SPECTRUM SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 2
SPECTRUM SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
SPINAL ELEMENTS
  SUBSTANTIALLY EQUIVALENT 1
SPINAL ELEMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 6
SPINAL STABILITY, LLC
  SUBSTANTIALLY EQUIVALENT 1
SPINE INNOVATION, LLC
  SUBSTANTIALLY EQUIVALENT 1
SPINE WAVE, INC.
  SUBSTANTIALLY EQUIVALENT 3
SPINEART SA
  SUBSTANTIALLY EQUIVALENT 1
SPINEEX, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINEFRONTIER, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINEOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINEVISION, S.A.S.
  SUBSTANTIALLY EQUIVALENT 2
SPINEWORXX AG
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TDM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VY SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 4
XENIX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ZAVATION MEDICAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 6
ZHEJIANG DECANS MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZSFAB, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 640 640
2021 622 627
2022 618 630
2023 576 578
2024 729 731
2025 827 827
2026 287 287

Device Problems MDRs with this Device Problem Events in those MDRs
Break 891 894
Migration 601 604
Adverse Event Without Identified Device or Use Problem 489 490
Fracture 419 428
Mechanical Problem 386 386
Device-Device Incompatibility 354 355
Material Deformation 140 141
Compatibility Problem 136 136
Mechanics Altered 111 111
Insufficient Information 106 108
Material Integrity Problem 93 93
Collapse 81 81
Mechanical Jam 78 78
Use of Device Problem 68 68
Migration or Expulsion of Device 67 67
Material Twisted/Bent 56 56
Appropriate Term/Code Not Available 54 54
Patient Device Interaction Problem 53 53
Detachment of Device or Device Component 47 47
Device Dislodged or Dislocated 42 42
Material Fragmentation 41 41
Device Sensing Problem 24 24
Loosening of Implant Not Related to Bone-Ingrowth 24 24
Malposition of Device 24 24
Difficult to Insert 23 24
Incorrect, Inadequate or Imprecise Result or Readings 19 19
No Apparent Adverse Event 17 17
Improper or Incorrect Procedure or Method 17 17
Physical Resistance/Sticking 17 17
Entrapment of Device 16 16
Crack 15 15
Device Slipped 13 13
Naturally Worn 12 12
Unintended Movement 11 11
Product Quality Problem 10 10
Manufacturing, Packaging or Shipping Problem 10 10
Positioning Problem 10 10
Activation Failure 9 9
Biocompatibility 9 9
Device Damaged by Another Device 9 9
Difficult to Remove 9 9
Difficult to Advance 9 9
Expulsion 8 8
Activation, Positioning or Separation Problem 8 8
Contamination /Decontamination Problem 7 7
Osseointegration Problem 7 7
Difficult or Delayed Positioning 7 7
Activation Problem 7 7
Device Handling Problem 7 7
Failure to Eject 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2458 2472
Pain 354 356
Insufficient Information 309 316
No Known Impact Or Consequence To Patient 176 176
Failure of Implant 145 145
No Consequences Or Impact To Patient 131 131
Unspecified Infection 104 104
Foreign Body In Patient 89 89
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 82 82
No Code Available 81 81
Nerve Damage 80 81
Device Embedded In Tissue or Plaque 79 79
Non-union Bone Fracture 74 74
Unspecified Tissue Injury 67 68
Osteolysis 57 57
Hematoma 48 48
Post Operative Wound Infection 46 46
Bone Fracture(s) 39 39
Joint Laxity 38 38
Neuropathy 34 34
Unspecified Nervous System Problem 33 33
Inadequate Osseointegration 32 32
Hemorrhage/Bleeding 28 28
Cerebrospinal Fluid Leakage 26 26
Numbness 26 26
Laceration(s) 23 23
Spinal Cord Injury 21 21
Vertebral Fracture 20 20
Intervertebral Disc Compression or Protrusion 19 19
Perforation of Vessels 19 19
Stenosis 17 17
Hypersensitivity/Allergic reaction 17 17
Unspecified Musculoskeletal problem 16 16
Injury 16 16
Ambulation Difficulties 16 16
Muscle Weakness 15 15
Spinal Column Injury 15 15
Fall 14 14
Wound Dehiscence 14 14
Paralysis 14 14
Cyst(s) 11 11
Pulmonary Embolism 11 12
Discomfort 11 11
Arthritis 11 11
Dysphagia/ Odynophagia 10 10
No Patient Involvement 10 10
Tissue Damage 9 9
Impaired Healing 9 9
Weakness 9 9
Sepsis 8 8

Recalls
Manufacturer Recall Class Date Posted
1 Advanced Research Medical, LLC II Apr-29-2024
2 Alphatec Spine, Inc. II Jan-30-2025
3 CTL Medical Corporation II Jul-04-2020
4 CoreLink LLC II Jan-12-2023
5 DePuy Spine, Inc. II Jul-01-2022
6 Globus Medical, Inc. II Aug-22-2020
7 Innovasis, Inc II Sep-17-2024
8 K2M, Inc II Jun-01-2021
9 Medicrea International II Jan-09-2026
10 Medicrea International II Aug-24-2023
11 Medicrea International II Feb-12-2020
12 Medtronic Sofamor Danek USA Inc II Nov-21-2025
13 Medtronic Sofamor Danek USA, Inc II Apr-20-2021
14 Orthofix U.S. LLC III Dec-11-2025
15 Orthofix U.S. LLC II Sep-11-2025
16 Orthofix U.S. LLC II Mar-21-2025
17 SEASPINE ORTHOPEDICS CORPORATION II Sep-11-2025
18 Stryker Spine II Apr-20-2021
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